FDA Device recall Z-0598-2026
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its access…
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its access… by Noah Medical, citing due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0598-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-12 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Noah Medical |
| Distribution | CA, CO, ID, IL, IN, MA, MD, MN, MO, NC, NJ, NY, OH, PA, SC, TN, VA, WI, WV, WY |
Product
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
Reason
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Identifiers
| code_info | Lot Code: Product Code: EOQ UDI: 00850048825048 SN: included in Customer Notification Letter (template) CRB-1502 CRB-15…Lot Code: Product Code: EOQ UDI: 00850048825048 SN: included in Customer Notification Letter (template) CRB-1502 CRB-1530 CRB-1558 CRB-1503 CRB-1531 CRB-1560 CRB-1508 CRB-1534 CRB-1562 CRB-1513 CRB-1535 CRB-1563 CRB-1514 CRB-1537 CRB-1564 CRB-1515 CRB-1539 CRB-1565 CRB-1516 CRB-1540 CRB-1566 CRB-1518 CRB-1541 CRB-1567 CRB-1519 CRB-1542 CRB-1568 CRB-1520 CRB-1545 CRB-1570 CRB-1521 CRB-1546 CRB-1571 CRB-1522 CRB-1553 CRB-1573 CRB-1523 CRB-1554 CRB-1574 CRB-1524 CRB-1555 CRB-1559 CRB-1525 CRB-1556 CRB-1569 CRB-1528 CRB-1557 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0598-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.